Capricor Therapeutics Shares Surge After FDA Meeting Announcement on Cell Therapy

Capricor Therapeutics (CAPR) shares surged 9% following FDA meeting discussions on cell therapy Deramiocel. Analysts forecast a 125.88% upside from the current share price, with a current brokerage recommendation of "Outperform." The company has rescheduled its Q2 2025 financial release to August 11.

Capricor Therapeutics (NASDAQ: CAPR) shares have surged by 9% following a recent FDA meeting to discuss the regulatory path for the company's Biologics License Application (BLA) for its lead cell therapy candidate, Deramiocel. The meeting, scheduled for August 11, 2025, is a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the approval process for Deramiocel, which is aimed at treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD).

The meeting has led to a significant increase in investor confidence, with analysts forecasting a 125.88% upside from the current share price. The company has also rescheduled the release of its second-quarter 2025 financial results to August 11, 2025, following the market close. This rescheduling is to accommodate the FDA meeting and provide a comprehensive corporate update.

Deramiocel, an allogeneic cardiac-derived cell therapy, has shown promise in preclinical and clinical studies, indicating its potential to preserve muscle function in muscular dystrophies such as DMD. The company's exosome-based therapeutics, developed using its proprietary StealthX™ platform, are also in preclinical development for various diseases.

The rescheduling of the financial results release demonstrates Capricor's commitment to transparency and allows investors to stay informed on both financial performance and strategic developments. However, the meeting with the FDA could imply potential regulatory challenges ahead for the approval of Deramiocel, indicating uncertainty in the product's market viability.

References:
[1] https://www.capricor.com/investors/news-events/press-releases/detail/322/capricor-therapeutics-announces-type-a-meeting-scheduled
[2] https://www.quiverquant.com/news/Capricor+Therapeutics+Schedules+FDA+Meeting+to+Discuss+Deramiocel+BLA+for+Duchenne+Muscular+Dystrophy